Health Canada on Advanced Manufacturing and Other Trends

Dr. Lourenco covered several topics, including new active substances (NAS); innovative cell and gene therapies; adaptive artificial intelligence and machine learning; medical devices; advanced therapeutic products (ATP); regulatory agility; and modernizing clinical trial regulations. She also discussed international collaboration and provided examples of harmonized publications with the International Council for Harmonisation (ICH) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S).

She noted that in 2022, Health Canada approved 44 NAS, marking an increase over the 42 approved in 2021. Dr. Lourenco added that the rise in approvals signals a positive trend in the development of new drugs in Canada. Half of the new drugs approved in 2022 were aimed at treating diseases. She also shared that over the past six years, more than 40% of the NASs approved in Canada have been classified as “orphan drugs,” in either Europe or the United States, as they are medications specifically developed to treat rare diseases or conditions. This, she said, indicates that Canada is actively supporting the advancement of treatments for these often-overlooked diseases and medical conditions that affect a small portion of the population.

Other recently approved medicines are those specifically designed to address significant public health concerns, such as cancer, inherited diseases, diabetes, and antimicrobial resistance, among others. Once more, these medications are often customized for individual patients and manufactured at the point-of-care. Accordingly, they require flexible and innovative manufacturing processes; however, regulatory oversight is essential for these products. She reiterated that accompanying these advancements are complexities in supply chains, the need to utilize data systems, artificial intelligence issues, and necessary real-world evidence (RWE) to help better manage the drug life cycle. While these challenges exist, they also present opportunities for improvement and progress.

Dr. Lourenco emphasized that a flexible regulatory environment supports economic growth as well as innovation in the health and biosciences sector. For example, in 2018 the Health and Bio-Sciences Economic Strategy Table and the Advisory Council on Economic Growth identified improvement opportunities. Also, to enhance Canada's position as a preferred destination for product submissions, in 2019 Health Canada launched a regulatory modernization plan. The plan aims at creating a modern, agile, and internationally aligned system. In addition to these initiatives, Health Canada created a multi-year plan to run from 2019 to 2024 and focused on policy and regulatory modernization.

“The goal is to have a pathway that allows Health Canada to regulate products in a flexible and risk-based manner,” said Dr. Lourenco.

She added that modernizing clinical trial regulations will provide a crucial step toward encouraging clinical trials in Canada and, at the same time, creates an environment for supporting safe innovation. She suggested that transparency is a key principle in modernizing clinical trial regulations and that the revealing trial results and information in a public registry is important as it provides researchers and the public with the opportunity to share valuable knowledge and insights.

Artificial Intelligence

Moving to discussing artificial intelligence (AI) and its emergence as a powerful tool in various sectors, including healthcare, product development, and regulation, Dr. Lourenco cited AI potential for use in pharmacovigilance and how AI has shown great potential as Health Canada has undertaken several projects in this domain.

She highlighted projects aimed at developing a “natural language” training data set to train computer models to better understand written text in scientific literature. She also noted that Health Canada is collaborating with Swissmedic, the Swiss regulatory authority, in testing their Literature Search Application (LISA) tool for signal detection and assessments. She said that this collaboration highlights the importance of international cooperation in harnessing the potential of AI in healthcare and that the rapid evolution of AI necessitates the establishment of international guidance to ensure the principles and appropriate utilization of AI in the healthcare sector.

In addition, The Council for International Organizations of Medical Sciences (CIOMS) Working Group XIV Artificial Intelligence for use in Pharmacovigilance has been established, with Health Canada actively participating. The objective is to establish and promote principles and guidance for the use of AI and its intelligent augmentation in pharmacovigilance.

Dr. Lourenco focused on Health Canada's involvement in other initiatives, such as the CIOMS Working Group XIV, who are also exploring the potential benefits as well as the challenges of AI’s use in pharmacovigilance. She expressed that by embracing AI, Health Canada aims to enhance the safety and effectiveness of health products while ensuring regulatory compliance.

Rolling Scientific Review Processes and Conditional Approvals

According to Dr. Lourenco, during the COVID-19 pandemic, Health Canada leveraged a rolling scientific review processes to expedite approval of critical medical products. She said that the resource-intensive nature of this approach makes product review faster than standard review processes, and that this provides benefits to both the greater society and to patients during a health emergency. This rolling review approach is aimed at allowing for the evaluation and authorization of products in real time by ensuring that the products meet safety and efficacy standards. By eliminating the traditional sequential review process, Health Canada was able to fast-track the availability of essential medical supplies and treatments by allowing for data submission for certain drugs as they became available, thereby enabling conditional approvals.

To further accelerate the availability of necessary medical interventions, she explained that Health Canada utilized conditional approvals that granted authorization with specific terms and conditions, helping to ensure that products available to the public even as ongoing assessments and data collection continued. This enabled faster access to life-saving treatments and vaccines, but without compromising safety standards.

Exploring Technological Advancements

Dr. Lourenco told attendees of the 2023 ISPE Annual Meeting & Expo that Health Canada will explore a diverse range of technological advancements by observing and studying advancements. She stressed that the agency wants to stay informed about the latest breakthroughs that could transform healthcare and improve patient outcomes, suggesting that this forward-thinking approach will allow Health Canada to be better prepared for the challenges posed by the COVID-19 pandemic. She also mentioned that Canada is investing in its manufacturing life sciences sector and, beginning in 2021, the country will invest $2.2 billion over seven years in an effort to grow the sector and ensure readiness for future pandemics as well as other health emergencies.

Enhancing International Collaboration in Addressing Trends and Challenges

One of the primary objectives of Health Canada’s international collaboration is to align high-level policy initiatives, such as the one with the International Coalition of Medicines Regulatory Authorities (ICMRA), an organization that facilitates discussion and cooperation among medicines regulatory authorities worldwide and through regulatory bodies can collaborate on regulatory policies, share best practices, and enhance the harmonization of drug regulations. She also explained how international collaboration also plays a vital role in ensuring the safety and efficacy of drugs during the submission review and post-market phases when regulatory authorities engage in coordinated reviews and information exchange to enhance the evaluation and monitoring processes. Once more, the collaborative approach helps identify potential risks, provides data sharing and ensures prompt dissemination of safety information.

Summary and Conclusion

In conclusion, Dr. Lourenco repeated her observation that AI holds tremendous potential in supporting health, product development, and regulation. She also reiterated that Health Canada's ongoing projects and collaborations, along with international guidance, are vital for harnessing AI’s potential and ensuring its appropriate use in healthcare. As AI continues to evolve, she said that it is essential to foster collaboration and establish guidelines to maximize its benefits while safeguarding patient safety and privacy.

She reflected on how the COVID-19 pandemic experience tested the resilience and responsiveness of Health Canada. through the implementation of temporary legislative and regulatory measures, rolling scientific review processes, conditional approvals, and collaboration with partners. Health Canada, she said, has demonstrated its commitment to protecting public health and that the lessons learned from the pandemic will – undoubtedly - inform future strategies and enhance Canada's preparedness to effectively respond to public health emergencies.

Her concluding remarks also focused on the modernization of clinical trial regulations in Canada, which aimed at creating an environment that supports safe innovation. By authorizing and overseeing broader clinical trials, tailoring requirements to risk, lightening requirements for new uses of approved drugs, and ensuring transparency through disclosure, she said that Canada is fostering a more supportive ecosystem for clinical trials. Additionally, efforts to align regulations across product lines and adapt to emerging trends, will keep Canada at the forefront of clinical trial research.

Finally, she noted that international collaboration is essential for addressing global trends and challenges and that the COVID-19 pandemic further emphasized the need for enhanced cooperation among nations. She cited the efforts of organizations such as the ICMRA, the World Health Organization (WHO), Health Canada, the European Medicines Agency (EMA), and the U.S. Food and Drug Administration (USFDA), and others, all of whom are actively working towards aligning policies, building capacity, providing support, and facilitating coordinated reviews. She maintained that through collaborative efforts, we can effectively address global challenges, promote public health, and ensure the safety and quality of medicines worldwide.

Disclaimer: This is an informal summary of a keynote presentation made on 18 October at the 2023 ISPE Annual Meeting & Expo in Las Vegas, Nevada. It has not been vetted by any of the agencies or regulators cited in this article, and should not be considered the official positions of any of the agencies referenced.